Update to the Manufacturing Principles for medicines, APIs & sunscreens

On 1 July 2022 the TGA adopted the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-15) issued, 1 May 2021, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens.

Why did the TGA adopt version 15 of the Guide to GMP?

The GMP guide is regularly updated and adopted by the TGA to:

• Provide guidance for the management of new technologies;
• Address gaps in existing compliance requirements;
• Manage risks identified through inspections and regulation;
• Facilitate continuous improvements in the way medicines are manufactured.

What are the main changes?

The changes in version 15 relate to Annex 2 - Biological Medicines, which has been split into two sub-annexes:

• Annex 2A 'Manufacture of advanced therapy medicinal products for human use'; and
• Annex 2B 'Manufacture of biological medicinal substances and products for human use'.

Annex 2A contains expanded and additional guidance specific to the manufacture of ATMP medicinal products, while Annex 2B remains mostly unchanged from the Annex 2 found in version 14 of the PIC/S guide but with ATMP products excluded from the scope of application. Just as in previous versions of the PIC/S guides, Annexes 2A/B apply to Biological Medicines including those derived from animal cells and/or tissues.

Alternatively, biologicals that comprise, contain or are derived from human cells and tissues, or are specified as a biological by the Secretary, must comply with the Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products.

How has the new Guide to GMP been adopted?

This adoption of the PIC/S Guide to GMP (PE009-15, 1 May 2021) commenced on 1 July 2022 from which point, GMP inspectors will use the new Guide to GMP during inspections.

Compliance with the basic requirements of the PIC/S Guide to GMP (PE009-15, 1 May 2021) is expected from the adoption date.

The TGA has held a range of industry consultations over the past year and will continue to work with industry to develop further interpretive guidance where required.

Further guidance regarding the adoption and interpretation on the PIC/S guide to GMP will published on the TGA website.

What action do manufacturers need to take now?

Manufacturers should:

• Review the PIC/S Guide to Good Manufacturing Practice PE009-15 and ensure you are familiar with the requirements relevant to your manufacturing operations.
• Check the TGA website for regular updates on the adoption of the PIC/S Guide to GMP PE009-15.